Pigment orange 16

ピグメントオレンジ16

[CAS No. 6505-28-8]

Dianisidine orange

ジアニシジンオレンジ

Molecular formula: C34H32N6O6 Molecular weight: 620.65

ABSTRACT

A single dose oral toxicity test of pigment orange 16 revealed an LD50 value of more than 2000 mg/kg for both sexes.

Pigment orange 16 was studied for oral toxicity in rats in a 28-day repeat dose toxicity test at doses of 0, 100, 300 and 1000 mg/kg. No deaths were observed in either sex. Repeated administration at 1000 mg/kg did not affect physiological function or morphological features. Thus, the NOEL for the 28-day repeat dose oral toxicity test of pigment orange 16 is considered to be 1000 mg/kg/day for males and females.

Pigment orange 16 did not induce gene mutations in bacteria under the conditions of this study.

In vitro chromosomal aberration tests using cultured cells (CHL/IU) were conducted to assess the potential of pigment orange 16 to induce chromosomal aberrations.

Pigment orange 16 did not induce chromosomal aberrations in cultured cells under the conditions of this study.

SUMMARIZED DATA FROM THE STUDIES

1. Single Dose Oral Toxicity 1)

Purity

:

>99 %

Test species/strain

:

Rat/Crj:CD(SD)IGS

Test method

:

OECD Test Guideline 401

Route

:

Oral(gavage)

Doses

:

Males and females, 0(vehicle), 2000 mg/kg

Number of animals/group

:

Males, 5; females, 5

Vehicle

:

Corn oil

GLP

:

Yes

Test results:

No deaths occurred in any group. Mucous feces attributable to the administration of corn oil were observed in controls on the administration day and orange colored feces in both sexes of the treated group on the next day. No effects were found on body weights or autopsy findings.

The LD50 value was concluded to be more than 2000 mg/kg for both sexes.

2. Repeat Dose Toxicity 1)

Purity

:

>99 %

Test species/strain

:

Rat/Crj:CD(SD)IGS

Test method

:

Guideline for 28-Day Repeated Dose Toxicity Test in Mammalian Species (Chemical Substances Control Law of Japan)

In the repeat dose study, no deaths were observed in either sex. The animals in the test substance groups excreted orange-colored feces due to the test substance continuously from the 2nd day to the end of administration period, but no other changes attributable to the test substance administered were observed regarding the general condition of the animals. There were no particular changes thought to have relevance to the test substance administration in parameters for body weight, food consumption, urinalysis, hematology, blood chemistry, organ weight and pathology.

Thus, the NOEL for the 28-day repeat dose toxicity is considered to be 1000 mg/kg/day for males and females.